magnetic resonance guided focal stereotactic body radiation therapy for localized prostate cancer

Conditions: Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer

Summary: this pilot clinical trial studies magnetic resonance (mri)-guided focal stereotactic radiosurgery (srs) in treating patients with low- or intermediate-risk localized prostate cancer. stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

primary objectives: i. evaluate the correlation of histopathology findings in comparison to regions of the prostate reported to be suspicious for harboring tumor burden on multiparametric mri report/s. ii. demonstration of the dosimetric and radiobiological advantages of focal stereotactic body radiation therapy (sbrt) versus whole-gland radiation therapy. iii. evaluation of clinical outcomes in focal sbrt for localized prostate cancer. outline: patients undergo 3 fractions of mri-guided focal srs every other day for 1 week. patients undergo additional mri scans between the 2nd and 3rd fractionated treatments, at 6 months following the end of radiation therapy, and at 12 and 24 months. after completion of study treatment, patients are followed up every 3 months for up to 24 months.

Eligibility criteria:
inclusion criteria: * patients must have a histologically confirmed diagnosis of adenocarcinoma of the prostate * patient must have a history/physical examination with digital rectal examination of the prostate within 90 days prior to screening * eastern cooperative oncology group (ecog) performance status must be level 0 or 1 within 60 days prior to registration * patient must have a histological evaluation of the prostate biopsy with assignment of a gleason score to the biopsy material; gleason scores ≤ 7(3+4) * serum creatinine ≤ 1.5 times upper limit of institutional normal (normal: ≤ 1.17 ml/min/1.73 m\^2) * clinical stage a ≤ t1-t2a (american joint committee on cancer \[ajcc\] 7th edition) * prostate specific antigen (psa) ≤ 10 ng/ml within 90 days prior to registration; psa should not be obtained within 10 days after prostate biopsy * subjects must have the ability to understand and the willingness to sign a written informed consent document * patient willing and able to complete the expanded prostate cancer index composite (epic) questionnaire (baseline, 6, 12 and 24 months post end of radiation therapy) * patients must be able to undergo an mri with contrast * bone scan completed within 90 days exclusion criteria: * evidence of distant metastases * regional lymph node involvement * previous radical surgery (prostatectomy), cryosurgery, or high intensity focused ultrasound (hifu) for prostate cancer * previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy * previous hormonal therapy, such as luteinizing hormone-releasing hormone (lhrh) agonists (e.g., goserelin, leuprolide) or lhrh antagonists (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., diethylstilbestrol \[des\]), or surgical castration (orchiectomy) * use of finasteride within 30 days prior to registration; psa should not be obtained prior to 30 days after stopping finasteride * use of dutasteride within 90 days prior to registration; psa should not be obtained prior to 90 days after stopping dutasteride * previous or concurrent cytotoxic chemotherapy for prostate cancer * severe, active co-morbidity, defined as follows: * unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months * transmural myocardial infarction within the last 6 months * acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration * hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol; (patients on coumadin or other blood thinning agents are eligible for this study) * acquired immune deficiency syndrome (aids) based upon current centers for disease and control (cdc) definition; note, however, that human immunodeficiency virus (hiv) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients * patients unable to undergo an mri with contrast